510(k) K760787— LIBERATOR/STROLLER

Substantially Equivalent

Burditt & Calkins-Siemens-Elema

Clearance details

Applicant
Burditt & Calkins-Siemens-Elema
Product code
Code BYJ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BYJ

product code BYJ
Death
16
Total
16

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.